Pharmacy & Therapeutics - November 2008 - (Page 674)

Pharmaceutical Approval Update control of, physicians who are qualified in the safe use and handling of radionuclides and whose experience has been approved by the appropriate government agency. Dosing is based on the radioactivity determined via a calibration system immediately before administration. Keeping the patient hydrated is essential for promoting hydration so that the patient will be able to void frequently before and after the injection. To minimize radiation to the bladder, staff members should advise patients to void frequently for the first 48 hours after receiving the injection. Thyroid blockade: Before the injection is given, the clinician administers potassium iodide oral solution or Lugol’s solution (equivalent to 100 mg of iodide for adults, or adjusted for a child’s weight in children) or potassium perchlorate (400 mg for adults, adjusted for body weight) to block the uptake of iodine-123 by the thyroid gland. The blocking agent is given at least one hour before the injection. Preparation: Before administration, the iobenguane 123I injection vial is inspected for particulate matter and discoloration. Aseptic procedures and a radiation-shielding syringe are used during administration. The dose is given as an IV infusion over one to two minutes. A subsequent injection of 0.9% sodium chloride may be used to ensure full delivery of the dose. Adult dose: For adults 16 years of age and older, the recommended dose is 10 mCi (370 MBq). Pediatric dose: For children younger than 16 years of age weighing 70 kg or more, the recommended dose is 10 mCi. For children younger than 16 years of age weighing less than 70 kg, the dose should be calculated according to the patient’s weight. The benzyl alcohol in the injection may cause serious adverse reactions in premature or low-birth-weight infants. Dosage form: The product is supplied as 5 mL of sterile solution for IV injection in a single-use vial that contains 2 mCi/mL (74 MBq) at the calibration time). Commentar y: Neuroblastoma is the most common extracranial solid tumor of young children up to five years of age, and pheochromocytoma is a rare tumor that typically affects adults. Both tumors usually arise from tissues of the sympathetic nervous system, usually the adrenal glands. These tumors, when small, can be difficult to detect at an early stage because symptoms may be nonspecific. Iobenguane 123I Injection helps detect these rare neuroendocrine tumors in children and adults by providing high-quality images at the initial diagnosis and at later examinations when relapse or recurrence is suspected. The images reflect the behavior of the tumor cells, allowing clearer differentiation of even small tumors from nonmalignant tissues with a similar appearance. The injection provides valuable additional information to complement anatomic imaging procedures and should greatly improve the assessment of tumors that often present diagnostic challenges for clinicians. Sources: http://md.gehealthcare.com; www.fda.gov I 674 P&T® • November 2008 • Vol. 33 No. 11 http://md.gehealthcare.com http://www.fda.gov

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - November 2008

Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

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